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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K923116
Device Name COMBINE II WETPROOF PAD
Applicant
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Applicant Contact SHAUNA MINER
Correspondent
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Correspondent Contact SHAUNA MINER
Regulation Number878.4014
Classification Product Code
NAB  
Date Received06/25/1992
Decision Date 10/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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